Current Controversies of Stem Cell Therapies

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1 Current Controversies of Stem Cell Therapies Professor Minghao Zheng, MD, PhD, FRCPath, FRCPA Medical School Associate Dean, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, WA, 6009

2 Declaration of Interest I declare that in the past three years I have: held shares in Orthocell Ltd; received institutional support from NHMRC, ARC Signed: minghao zheng

3 What are the controversies surrounding stem cell therapies? How do we define the boundaries of practice? Is there a place for stem cell therapy in Orthopaedics

4 Life starts with blastocyte stem cells Inner cluster mass (ICM) of blastocytes

5 Stem cell therapy is not new First cellular therapy in 1959 Dr Georges Mathé Conducted first bone marrow cell therapy on five Yugoslavian nuclear workers whose own marrow had been damaged by irradiation

6 E Donnall Thomas Development of bone marrow transplantation as a treatment for leukaemia; In 1990, he shared the Nobel Prize in Physiology or Medicine with Joseph E. Murray for the development of cell and organ transplantation.

7 Induced Pluripotent Stem Cells (ipsc) Shinya Yamanaka 2012 Turning Back the Cellular Clock: A Farewell to Embryonic Stem Cells?

9 Stem cells the public perception

10 Stem cells are not a miracle There is emerging evidence it may work to repair corneas to prevent the most common causes of blindness. It is looking promising in cerebral palsy, to treat lung damage in premature babies and osteoarthritis among many others. But for all the other ailments, from antiageing to autism, spinal cord injury to Alzheimer s disease, the consensus from Australia s leading experts is; there is not a shred of evidence it works.

12 Stem cells are required more research, We don t want to see Lack of sufficient pre-clinical evaluation; Exploitation of regulatory loopholes; Lack of research and clinical evidence; Overpromise;

13 Shapiro et al, A Prospective, Single-Blind, Placebo- Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med Aug 26 Patients experienced a similar relief of pain in both BMAC- and saline-treated arthritic knees!

16 Common adverse events of stem cells therapies Same day procedure is relatively safe (SD); Fat oil from adipose tissue cause pain (AD); Cultured MSCs promote disease progression (CE).

18 Australia Research Council launches roadmap for Australian stem cell science Position statement 21 March 2016

19 Recommendations Clinicians to establish a boundary of clinical practice; Improve community engagement and awareness of stem cell research and therapy; Improve patient access to clinical trials; Facilitate cross disciplinary collaboration

20 Liposuction stem cell therapy Stem cell clinics

21 What are the controversies surrounding stem cell therapies? How do we define the boundaries of practice? Is there a place for stem cell therapy in Orthopaedics

22 MACI - Autologous chondrocyte implantation for cartilage injuries; ATI - Autologous tendon cell injection for tendinopathy and tear.

23 Am J Sport Med :1259

26 GMP Lab Matrix induced ACI (MACI) Cell-scaffold construct 30 minutes surgery; small incision or arthroscope

27 Zheng et al 2006

28 SUMMIT Trial

29 MACI - Autologous chondrocyte implantation for cartilage injuries; ATI - Autologous tendon cell injection for tendinopathy and tear.

30 Research Evidence of ATI Substitution of tendon cell by injection to central tear site improve tendon healing in tendinopathy. Chen et al 2007; 2011; Wu et al 2011; Zheng et al Science (supplementary) 2012

31 Feridex cell tracking within the tendon J Chen, M.B.Ph.D.et al TISSUE ENGINEERING: Part A 17:15, 2011 Cover page

32 Clinical Evidence: level III/IV AJSM2013 AJSM 2014 BMJ 2013

33 Indication Expansion = 376 cases Rotator Cuff =36 Hamstring Tendon = 9 Tennis elbow = 52 Patellar Tendon = 27 Gluteal Tendon =17 Achilles Tendon =17 Adductor and Biceps = 3

34 Post-market surveillance indicating that 70.7% of patients were satisfied with the outcome of their Ortho-ATI treatment (including both the resolution of symptoms and ability to resume daily activities).

35 Level II Clinical Evidence: Outcome of ATI RCT study in Holland

36 Level II Clinical evidence Comparison of ATI with surgery in patients with chronic resistant lateral epicondylitis (ACTRN p),

37 Treatment principle and algorithm of tendinopathy Bhabra et al JOSM 2016 Pathogenesis Treatment principle Overuse Avoid re-injury Rest Angiofibroblastic hyperplasia Mechanical induction of intrinsic repair Physiotherapy Degenerative change of tendon cell & matrix Control of pain Injection Matrix breakdown & Fatigue healing Structural changes with mechanical failure Substitution of tendon progenitor cells for tendon repair Correction of biomechanics & decompression Cell Surgery

38 Take home messages - Clinicians need to define their boundary of practice for stem cell therapy; - Any stem cells injection into joint have shown not working; - Autologous chondrocyte implantation works for localised cartilage injury and is an FDA approval cellular product; - Autologous Tenocyte Injection is working but need higher level of clinical evidence (level II and above).

39 THANK YOU

Boundaries of Stem Cells, approved cellular therapy technologies

Boundaries of Stem Cells, approved cellular therapy technologies Professor Minghao Zheng, MD, PhD, FRCPath, FRCPA Medical School Associate Dean, Faculty of Health and Medical Sciences, The University of